Postponement of MDR deadline for Class I products


The Medical Device Regulation (MDR) will be binding for all medical device manufacturers from 26.05.2020 and the implementation of this regulation will pose immense challenges for manufacturers, medical contract institutes and notified bodies. The 2nd amendment of the MDR of 25.11.2019 now grants manufacturers of Class I products a postponement. Class I products, which comply with the MDD (Medical Device Directive) and would have to be classified higher according to MDR, can continue to be marketed until 26.05.2024. This extension of the transition period will benefit suppliers of medical apps, among others, which are mostly class IIa or higher according to MDR, but which are already certified as class 1 (according to MDD). Manufacturers of material products and surgically invasive products can also benefit from the change. However, all manufacturers are required to implement the new requirements of the MDR now, including post-market surveillance, market surveillance and vigilance, as there is no deadline extension in these areas. The Medical Device Implementation Act (MPDG), which will be discussed in the Federal Council on 20.12.2019, also raises many questions for manufacturers and participating partners regarding its precise implementation. We will also support and advise you on the challenges of the MPDG.